The U.S. Food and Drug Administration (FDA) has begun to ask questions about the safety of AstraZeneca’s drug, Zurampic (lesinurad).
What is Zurampic?
According to Reuters, Zurampic, used in combination with febuxostat, is a treatment for Gout.
Originally developed by Ardea Biosciences, Zurampic was purchased by AstraZeneca for $1.26 billion in 2012. Sales of the drug are forecasted to reach $350 million by 2020, but it still is not considered to be a major contributor to AstraZeneca’s sales.
Staff reviewers of the FDA have begun to ask questions about the health risks of the drug. The questions stem from the higher death rates, cardiovascular issues, and kidney-related side effects that have been correlated with patients who took the medicine. Their findings were published in a preliminary review last Wednesday.
A panel of advisors will take into account the information from the review and provide a recommendation for the drug. This panel is independent of the FDA, and its advice will most likely be followed by the FDA.
Overview of Gout
- According to the Mayo Clinic, Gout is a complex form of arthritis that can affect anyone. It is characterized by attacks of pain which are sudden and severe, causing redness and tenderness at the joints.
- The most commonly affected joint is the big toe. Gout attacks hit suddenly, often in the middle of night.
- According to the U.S. Centers for Disease Control and Prevention (CDC):
- Gout affects about 8.3 million adults in the U.S. (about 3.9% of the population)
- It is more prevalent in men (5.9% vs. 2.0% of women)
- Among men, African American men are almost twice as likely to suffer from gout as white men (10.9% vs. 5.8%, respectively)
- Gout is linked to an increase risk of kidney stones and cardiovascular disease